FDA Warns Against Use of Opioid-Containing Cough and Cold Medications in Children

In January 2018, the Food and Drug Administration (FDA) announced that it is requiring labeling changes for prescription cough and cold medications that contain opioids (codeine or hydrocodone) to limit their use to adults 18 years of age or older.[1] The agency concluded that the risks of these medicines outweigh their benefits in children younger than 18.

About cough

Cough is a common symptom of illness among people of all ages, but particularly in children. Although it can be disruptive to children and their families, coughing helps to clear the throat and breathing airways.

Acute cough generally is caused by irritation to the upper respiratory tract, most often due to a viral infection. It usually begins suddenly, resolves spontaneously within a couple of weeks and does not require treatment.

Although many people self-medicate with over-the-counter (OTC) cough medications (including those that contain antihistamines and nasal decongestants), there is no good evidence that supports their effectiveness.[2] Therefore, Public Citizen’s Health Research Group has long advised against giving any OTC cough medications to children younger than 12 years of age.[3]

In addition, there is little to no evidence that prescription cough suppressants are effective in children.[4]

Opioid-containing cough medications

Available in combinations with other medications (such as antihistamines and decongestants), codeine and hydrocodone are the only opioids that have been approved to treat cough (see table, below, for a list of these medications). Public Citizen’s Health Research Group has designated all of these combination products as Do Not Use for both children and adults.

Both codeine and hydrocodone relieve cough by suppressing signals from the part of the brain that stimulates coughing.

Prescription Cough and Cold Medications That Contain Codeine or Hydrocodone

* Classified as Do Not Use by Public Citizen’s Health Research Group

The safety changes

FDA’s January 2018 safety announcement indicated that the agency is requiring labeling changes for prescription cough and cold medications that contain codeine or hydrocodone to limit their use to adults age 18 or older.[5]

The announcement advised health care professionals that cough and cold medications that contain these opioid ingredients are no longer approved for use in children for relief of cough. The agency further urged health care professionals to reassure parents that cough due to a cold or upper respiratory infection is selflimited and generally does not need to be treated.

The FDA took these actions after conducting an evidence review and convening a meeting of its Pediatric Advisory Committee,[6] both of which determined that the risks of these medications outweigh their benefits in children under 18 years of age.

The risks of these medications include overdose, slowed or difficult breathing, abuse, addiction, misuse and death.

The announcement also noted that the FDA is requiring the addition of safety information about the aforementioned risks to the black-box warning — the strongest warning that the agency can require — on the labeling of codeine- or hydrocodone-containing cough and cold medications, to be consistent with the risks described in the labeling of the prescription opioid medications that are indicated for the relief of pain.

What You Can Do

If you are a parent or a caregiver of a child who has an acute cough, never give the child any medications that contains codeine or hydrocodone to relieve cough. Instead, give the child plenty of fluids and use the following to relieve his or her coughing: cool (not warm) mist humidifier, saline nose drops or spray, and, for infants, nasal suctioning with a bulb or syringe with or without saline nose drops.[7] You also may give the child a teaspoonful of honey at bedtime if he or she is older than one year.[8],[9] Do not give a child (or an adult) who has mucus-producing cough any OTC cough or cold medication because coughing is the body’s natural way of ridding itself of secretions and decreasing infection. Moreover, these medications are generally ineffective.

Do not give a child benzonatate (TESSALON) to treat cough because this drug has been implicated in accidental ingestions in children under 10 years of age, resulting in overdose and death.[10]

Do not give the commonly used decongestant dextromethorphan (DELSYM), alone or in combination with other drugs, to children with cough because this drug is ineffective.[11]

Call your child’s doctor at the first sign of illness, including cough, if he or she is two months or younger.[12] Call your child’s doctor regardless of the age of your child if his or her cough worsens or becomes associated with wheezing or fever (102 degrees Fahrenheit or higher); if he or she is not eating or drinking; or if he or she is excessively cranky or sleepy. Seek emergency care if your child is choking, having difficulty breathing or swallowing, or coughing up bloody or pink-tinged phlegm.

References

[1]Food and Drug Administration. FDA drug safety communication: FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older. January 11, 2018. https://www.fda.gov/Drugs/DrugSafety/ucm590435.htm. Accessed June 3, 2018.

[2]Smith SM, Schroeder K, Fahey T. Over-the-counter (OTC) medications for acute cough in children and adults in community settings. Cochrane Database Syst Rev. 2014;Nov 24(11):CD001831.

[3]Lurie P, M.D., Barbehenn E. Public Citizen testimony on the availability of over-the-counter pediatric cough and cold formulations before the joint meeting of the Non-Prescription Drugs and Pediatrics Advisory Committees. October 19, 2007. https://www.citizen.org/our-work/health-and-safety/testimony-availability-over-counter-pediatric-cough-and-cold. Accessed June 3, 2018.

[4]Paul IM. Therapeutic options for acute cough due to upper respiratory infections in children. Lung. 2012;190(1):41-44.

[5]Food and Drug Administration. FDA drug safety communication: FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older. January 11, 2018. https://www.fda.gov/Drugs/DrugSafety/ucm590435.htm. Accessed June 3, 2018.

[6]Food and Drug Administration. Background document, Pediatric Advisory Committee meeting: Benefit/risk assessment of prescription opioid antitussive products for treatment of cough in pediatric patients. September 11, 2017. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/UCM573222.pdf. Accessed June 3, 2018.

[7]Food and Drug Administration. Use caution when giving cough and cold products to kids. February 8, 2018. https://www.fda.gov/Drugs/ResourcesForYou/SpecialFeatures/ucm263948.htm. Accessed June 3, 2018.

[8]Food and Drug Administration. Background document, Pediatric Advisory Committee meeting: Benefit/risk assessment of prescription opioid antitussive products for treatment of cough in pediatric patients. September 11, 2017. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/UCM573222.pdf. Accessed June 3, 2018.

[9]Cohen HA, Rozen J, Kristal H, et al. Effect of honey on nocturnal cough and sleep quality: A double-blind, randomized, placebo-controlled study. Pediatrics. 2012;130(3):465-471.

[10]WorstPills.org. Drug profile: benzonatate (TESSALON). August 31, 2017. /monographs/view/220. Accessed June 4, 2018.

[11]WorstPills.org. Drug profile: dextromethorphan (DELSYM). August 31, 2017. /monographs/view/206. Accessed June 3, 2018.

[12]Food and Drug Administration. Most young children with a cough or cold don't need medicines. July 18, 2017. https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm422465.htm. Accessed June 3, 2018.